EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2021 (No. 1)
PB 1 of 2021
Purpose
The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953 (the Act), is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.
PB 71 of 2012 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (equivalent brands, responsible persons, prescribing circumstances, maximum quantities, number of repeats, determined quantity and pack quantity, section 100 only status and prescriber bag only status).
Authority
This Instrument exercises various powers in Part VII of the Act, as set out below:
Pharmaceutical benefits listed on the PBS
Subsection 85(2) provides that the Minister may declare drugs and medicinal preparations to which Part VII applies. A drug or medicinal preparation for which there is a declaration in force under subsection 85(2) is a ‘listed drug’ (subsection 84(1)). Subsections 85(3) and 85(5) respectively provide that the Minister may determine the form or forms of a listed drug and the manner of administration of a form of a listed drug. A listed drug in a determined form with a determined manner of administration for that form is a pharmaceutical item (section 84AB). Subsection 85(6) provides that the Minister may determine a brand of a pharmaceutical item.
The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)). Under the provisions of section 84AK the Minister may determine the determined quantity and pack quantity for a brand of a pharmaceutical item.
Prescribing pharmaceutical benefits
Subsection 88(1) provides that a medical practitioner is authorised to prescribe a pharmaceutical benefit. Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).
Subsection 85(7) provides that the Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit.
Paragraph 85A(2)(a) allows the Minister to determine the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit (or of the pharmaceutical benefit where there is no pharmaceutical item) that may, in one prescription, be directed to be supplied on one occasion. Paragraph 85A(2)(b) also allows the Minister to determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated. The maximum quantities and repeats may be determined for all purposes or for particular purposes.
Supplying pharmaceutical benefits
Subsection 85(2A) provides that the Minister must declare that a particular listed drug can only be provided under a special arrangement under section 100 if the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100.
Subsection 85(2AA) provides that the Minister must declare that a particular listed drug can only be provided under one or more of the prescriber bag provisions if the PBAC has recommended under subsection 101(4AACA) that the drug be made available only under one or more of the prescriber bag provisions.
Subsection 85(6A) provides that the Minister may also determine for the purposes of paragraph 103(2A)(b) that a brand of a pharmaceutical item determined under subsection 85(6) is to be treated as equivalent to one or more other brands of pharmaceutical items.
Paragraph 85(7A) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under one or more of the prescriber bag provisions.
Paragraph 85(8)(a) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100.
Paragraph 85(8)(b) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100 for one or more of the circumstances determined for that pharmaceutical benefit under subsection 85(7).
Paragraph 88(1EB) provides that the Minister can list pharmaceutical benefits without determining any authorised prescribers for the benefit allowing the benefit to be supplied only.
Variation and revocation
Unless there is an express power to revoke or vary PB 71 of 2012 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 71 of 2012.
Subsection 101(4AAA) allows the Minister to, by legislative instrument, revoke or vary a subsection 85(2) declaration in relation to a drug or medicinal preparation. Advice from the PBAC is required if the effect of the legislative instrument would be that a drug or medicinal preparation would cease to be a listed drug (subsection 101(4AAB)).
Changes to PB 71 of 2012 made by this Instrument
Schedule 1 to this Instrument provides for the addition of the listed drug selexipag and forms of the listed drugs fluoxetine, terbutaline and trihexyphenidyl to the Schedule of Pharmaceutical Benefits. It also provides for the deletion of forms of the listed drugs ocriplasmin, ranitidine and tenofovir with emtricitabine and efavirenz from the PBS. In addition, it also provides for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs carfilzomib, lisdexamfetamine, methylphenidate and ruxolitinib.
Schedule 1 to this Instrument also provides for the following changes:
- the addition of 20 brands and deletion of 1 brand of existing pharmaceutical items;
- the alteration of a brand name for 2 existing brands of pharmaceutical items;
- the alteration of the responsible person code for 7 existing brands of pharmaceutical items;
- the addition of 1 responsible person to the list of responsible persons;
- the alteration of 1 responsible person name on the list of responsible persons; and
- the addition of 4 brands of existing pharmaceutical items to supply only.
These changes are summarised, by subject matter, in the Attachment.
Consultation
The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation. The PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits. The PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC. In addition, an industry nominee has been appointed to the PBAC membership under the PBS Access and Sustainability Package of reforms announced in May 2015. When recommending the listing of a medicine on the PBS, PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
Pharmaceutical companies are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings. This includes the company submission to the PBAC and involvement throughout the PBAC process, negotiations or consultation on price, guarantee of supply and agreement to final listing details.
It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that had already taken place.
General
A provision-by-provision description of this Instrument is contained in the Attachment.
This Instrument commences on 1 February 2021.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2021 (No. 1)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 1) and may also be cited as PB 1 of 2021.
Section 2 Commencement
This section provides that this Instrument commences on 1 February 2021.
Section 3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
The amendments in Schedule 1 involve the addition of a drug, the addition and deletion of forms of drugs, the addition and deletion of brands, the alteration of brand names, the alteration of responsible person codes for a number of brands of pharmaceutical benefits, the addition of a responsible person code, the alteration of a responsible person name, the addition of 4 brands of pharmaceutical items to supply only status, and the alteration of circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme. These changes are summarised below.
SUMMARY OF CHANGES TO THE PHARMACEUTICAL BENEFITS SCHEME
MADE BY THIS INSTRUMENT
Listed Drugs Added
Listed Drug |
Selexipag |
Forms Added
Listed Drug | Form |
Fluoxetine | Capsule 20 mg (as hydrochloride) (USP) |
Terbutaline | Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 120 doses |
Trihexyphenidyl | Tablet containing trihexyphenidyl hydrochloride 2 mg (USP) |
Forms Deleted
Listed Drug | Form |
Ocriplasmin | Solution concentrate for intravitreal injection 0.5 mg in 0.2 mL |
Ranitidine | Tablet, effervescent, 150 mg (as hydrochloride) |
Tenofovir with emtricitabine and efavirenz | Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg |
Brands Added
Listed Drug | Form and Brand |
Amlodipine | Tablet 5 mg (as besilate) (Pharmacor Amlodipine) |
Tablet 10 mg (as besilate) (Pharmacor Amlodipine) | |
Bosentan | Tablet 62.5 mg (as monohydrate) (Bosentan Cipla) |
| Tablet 125 mg (as monohydrate) (Bosentan Cipla) |
Codeine with paracetamol | Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol |
Esomeprazole | Tablet (enteric coated) 20 mg (as magnesium trihydrate) (Esomeprazole Mylan) |
| Tablet (enteric coated) 40 mg (as magnesium trihydrate) (Esomeprazole Mylan) |
Isotretinoin | Capsule 10 mg (Isotretinoin GX) |
| Capsule 20 mg (Isotretinoin GX) |
Lurasidone | Tablet containing lurasidone hydrochloride 40 mg (APO-Lurasidone) |
| Tablet containing lurasidone hydrochloride 80 mg (APO-Lurasidone) |
Methenamine | Tablet containing methenamine hippurate 1 g (Uramet) |
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) (Zotren 4) |
| Tablet 8 mg (as hydrochloride dihydrate) (Zotren 8) |
Phenelzine | Tablet 15 mg (as sulfate) (USP) (Phenelzine sulfate USP (Generic Health)) |
Posaconazole | Tablet (modified release) 100 mg (Pharmacor Posaconazole; POSACONAZOLE DR.REDDY'S) |
Sildenafil | Tablet 20 mg (as citrate) (Sildenafil PHT APOTEX) |
Spironolactone | Tablet 25 mg (Spironolactone Mylan 25) |
| Tablet 100 mg (Spironolactone Mylan 100) |
Brands Deleted
Listed Drug | Form and Brand |
Phenelzine | Tablet 15 mg (as sulfate) (USP) (Nardil) |
Alteration of Brand Name
Listed Drug | Form | Brand Name |
Bosentan | Tablet 62.5 mg (as monohydrate) | From: BOSENTAN DR. REDDY'S |
| Tablet 125 mg (as monohydrate) | From: BOSENTAN DR. REDDY'S |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person Code |
Ambrisentan | Tablet 5 mg | Volibris | From: GK |
| Tablet 10 mg | Volibris | From: GK |
Clonidine | Tablet containing clonidine hydrochloride 100 micrograms | Catapres 100 | From: BY |
| Tablet containing clonidine hydrochloride 150 micrograms | Catapres | From: BY |
Oxycodone | Capsule containing oxycodone hydrochloride 5 mg | Oxycodone BNM | From: LI |
| Capsule containing oxycodone hydrochloride 10 mg | Oxycodone BNM | From: LI |
| Capsule containing oxycodone hydrochloride 20 mg | Oxycodone BNM | From: LI |
Addition of Responsible Person Code
Responsible Person and Code |
Seekwell Pty Ltd (ZE) |
Alteration of Responsible Person Name
From: | To: |
Technipro Marketing Pty Ltd (TM) | Technipro PulmoMed Pty Ltd (TM) |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
Carfilzomib |
Lisdexamfetamine |
Methylphenidate |
Ruxolitinib |
Supply Only Status
Note: From 1 November 2020 Supply Only benefits are available on the Schedule for dispensing but not for prescribing, usually for a period of up to 12 months from when it is deleted.
Listed Drug | Form and Brand |
Cyproterone | Tablet containing cyproterone acetate 50 mg (Cyprocur 50) |
| Tablet containing cyproterone acetate 100 mg (Cyprocur 100) |
Zoledronic acid | Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL |
| Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL (Ostira) |
Documents Incorporated by Reference
Listed Drug | Document incorporated | Document access |
Ruxolitinib | Age-Adjusted Dynamic International Prognostic Scoring System (DIPSS). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003. The Age-Adjusted DIPSS is a medical diagnostic tool used to help assess the severity of myelofibrosis for younger patients (under 65 years old) by taking into account progression of disease over time and can be used to evaluate prognosis as a patient's condition evolves.
| The age-adjusted DIPSS is available for download for free from the Blood Journal website: https://ashpublications.org/blood/article/115/9/1703/27216/A-dynamic-prognostic-model-to-predict-survival-in Blood (2010) 115 (9): 1703–1708 |
Ruxolitinib | Dynamic International Prognostic Scoring System (DIPSS). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003. The DIPSS is a medical diagnostic tool used to help assess the severity of myelofibrosis by taking into account progression of disease over time and can be used to evaluate prognosis as a patient's condition evolves. | The DIPSS is available for download for free from the Blood Journal website: https://ashpublications.org/blood/article/115/9/1703/27216/A-dynamic-prognostic-model-to-predict-survival-in Blood (2010) 115 (9): 1703–1708 |
Ruxolitinib | International Prognostic Scoring System (IPSS). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003. The IPSS is a medical diagnostic tool used to help assess the severity of myelodysplastic syndrome, through the evaluation of the proportion of blast cells in a patient's bonemarrow, the type of chromosomal changes (if any) in the marrow cells, and the presence of one or more low blood cell counts (cytopenias). | The International Prognostic Scoring System (IPSS) is available for download for free from the Blood Journal website: https://ashpublications.org/blood Blood (1997) 89 (6): 2079–2088. |
Selexipag
| WHO Functional Classes for pulmonary arterial hypertension (PAH). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003. The WHO Functional Class system for PAH is used to define the severity of PAH symptoms and the impact they have on a patient’s day-to-day activities. | The WHO Functional Class system for PAH is available for download for free from the Pulmonary Hypertension Association Australia website: https://www.phaaustralia.com/page/11/classification-of-pulmonary-hypertension |
Diagnostic tools referenced in the Instrument
The following standard medical diagnostic tools are referenced in the Instrument but are not intended to incorporate a document by reference.
Listed Drug | Diagnostic tool | Purpose and use in the Instrument | Reason this reference does not serve to incorporate a document |
Selexipag | Six Minute Walk Test (6MWT) | The 6MWT is an assessment of performance ability in a variety of cardiopulmonary diseases. It provides important functional information that is not captured in standardized pulmonary function testing. Measurement must be reported on as part of the authority application for a number of PBS listed drugs. | The 6MWT is a process for obtaining physiological measurements and does not constitute a written record of information that must be referred to in order to determine whether statutory conditions have been met. The 6MWT is part of the standard diagnostic work-up for Pulmonary Arterial Hypertension. |
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 1)
(PB 1 of 2021)
This Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Instrument
The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 1) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the Principal Instrument) which determines the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (responsible persons, prescribing circumstances, schedule equivalence, maximum quantities, number of repeats, determined quantities, pack quantities, section 100 only status and prescriber bag only status).
The amendments in Schedule 1 involve the addition of a drug, the addition and deletion of forms of drugs, the addition and deletion of brands, the alteration of brand names, the alteration of responsible person codes for a number of brands of pharmaceutical benefits, the addition of a responsible person code, the alteration of a responsible person name, the addition of 4 brands of pharmaceutical items to supply only status, and the alteration of circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme.
Human rights implications
This Instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based. The pharmaceutical industry now has a nominee on the PBAC membership.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Thea Connolly
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health